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Prevention of Complications of Eye Surgery (ocr)
This study has been completed.
Sponsors and Collaborators: Isfahan University of Medical Sciences
None
Information provided by: Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00478907
  Purpose

This study was designed to investigate pre-operatively measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric strabismus surgery.


Condition Intervention Phase
Strabismus
Drug: KETAMINE, PROPOFOL, THIOPENTAL
Phase II

Drug Information available for: Propofol Ketamine Ketamine hydrochloride Thiopental Thiopental sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: phase2 Study of Prevention of Complications of Strabismus Surgery

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • incidence of OCR [ Time Frame: TWO YEARS ]

Secondary Outcome Measures:
  • TYPE OF DRUG PREVENTING OCR [ Time Frame: 2 YEARS ]

Enrollment: 300
Study Start Date: March 2004
Study Completion Date: March 2006
Detailed Description:

Objectives: Despite various proposed maneuver, successfully predicting an oculocardiac reflex (OCR) is difficult to achieve. This study was designed to investigate pre-operatively measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric strabismus surgery.

Methods: Three hundred patients were randomized to one of three anesthetic regimes: group P: propofol (2 mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group K: ketamine (2mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group T: thiopental (5mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction. OCR was defined as a 10% change in heart rate induced by traction.

Results: Incidence of OCR was significantly lower in patients in group k compared with patients in group T or P. Chi-square test results showed that the occurrence of OCR was significantly associated with difference of iris color (P=0.01). The occurrence of the OCR did not correlate with sex, age, duration of surgery, iris color, severity of MGP, number of EOM under tension, and type of mechanical stimulation of eye. Type of mechanical stimulation of eye or number of EOM under tension increased risk of developing OCR by 0.81 (95% CI, 0.66-0.98) and 1.29 (95% CI; 1.12-1.63) respectively.

Conclusions: Induction of anesthesia with ketamine is associated with least hemodynamic changes induced by OCR during strabismus surgery. The prediction of oculocardiac reflex propensity remains elusive.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 300 ASA physical status I or II patients, aged 2-18 years, who candidate for elective strabismus surgery

Exclusion Criteria:

  • trauma to eye, ASA III or IV, who had contraindication for using thiopental, ketamine, or propofol, had cardiovascular diseases or had taken cardiovascular drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478907

Locations
Iran, Islamic Republic of, Isfahan
Feiz Hospital
tehran, Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
None
Investigators
Study Chair: mohammad safavi, phd isfahan committee of research
Principal Investigator: hasan soltani, phd feiz hospital
  More Information

oculocardiac reflex ketamine  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 82390, no
Study First Received: May 24, 2007
Last Updated: May 24, 2007
ClinicalTrials.gov Identifier: NCT00478907  
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Isfahan University of Medical Sciences:
oculocardiac reflex; strabismus surgery;

Study placed in the following topic categories:
Ocular Motility Disorders
Motor neuro-ophthalmic disorders
Thiopental
Eye Diseases
Strabismus
Ketamine
Propofol
Ocular motility disorders

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Pharmacologic Actions
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Cranial Nerve Diseases
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009